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Study Comparing Vedolizumab and Infliximab for Children Aged 6-17 with Ulcerative Colitis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying ulcerative colitis, a condition that causes inflammation and sores in the lining of the large intestine. The study will compare two treatments: vedolizumab and infliximab. Vedolizumab is a medication that is not yet registered for use in children, while infliximab is a standard treatment. Both medications are given through an infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to assess the safety and effectiveness of these treatments in children aged 6 to 17 years who have ulcerative colitis. Participants will be randomly assigned to receive either vedolizumab or infliximab. The study will be conducted in a way that neither the participants nor the researchers know which treatment is being given, a method known as "double-blind." This helps ensure that the results are not biased. The study will also include a comparison with a placebo to better understand the effects of the treatments.

Throughout the study, the safety of the treatments will be closely monitored by tracking any side effects that occur. The effectiveness will be measured by observing changes in the symptoms of ulcerative colitis, such as improvements in inflammation and overall health. The study aims to provide valuable information on how these treatments work in children and to determine which treatment might be more beneficial for managing ulcerative colitis in this age group.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age (6 to 17 years) and the presence of moderate or severe ulcerative colitis, as defined by a Pediatric Ulcerative Colitis Activity Index (PUCAI) score of at least 30 points.
The assessment also checks for previous responses to standard treatments, such as corticosteroids or immunomodulatory drugs, and ensures that the condition is not limited to rectal inflammation.
Step 2
Randomization and treatment assignment
Participants are randomly assigned to receive either vedolizumab or infliximab. Both medications are administered as a solution for infusion, meaning they are given intravenously.
Vedolizumab is not registered for pediatric patients, while infliximab is used as a standard therapy.
Step 3
Treatment administration
The assigned medication is administered through an infusion. The frequency and dosage are determined by the study protocol, which is designed to ensure safety and effectiveness.
Participants will receive regular infusions over the course of the study, with the schedule tailored to the specific medication.
Step 4
Monitoring and follow-up
Throughout the study, participants are monitored for any adverse events related to the medication. This includes regular check-ups and assessments to track the safety of the treatment.
The study aims to evaluate the clinical response, which is defined as a decrease in PUCAI value by at least 20 points, and clinical remission, indicated by a PUCAI value of less than 10 points.
Step 5
Study completion
The study is expected to conclude by November 30, 2028. Upon completion, the data collected will be analyzed to assess the safety and effectiveness of the treatments.
Participants will receive a final assessment to determine the overall impact of the treatment on their condition.

Who can join the trial?

8 criteria

Participants must be between 6 and 17 years old.
Participants should have **ulcerative colitis** (UC), which is a condition affecting the colon, with moderate or severe symptoms. This is measured by a score of at least 30 points on the **PUCAI**, a tool used to assess the severity of UC.
Participants must have been diagnosed with UC at least one month before the screening visit.
Participants should not have responded to standard treatments, lost their response, or not tolerated at least one of the following treatments: **corticosteroids** (like prednisone or budesonide), or **immunomodulatory drugs** (such as AZA, 6-MP, MTX, cyclosporin). If using 5-ASA, corticosteroids, or immunomodulatory drugs, the dosage should remain stable for 2 weeks before starting the study medication.
Participants should have UC that affects areas beyond just the rectum, meaning it is not limited to rectal inflammation.
Participants should have a **Mayo Endoscopic Scale** score of at least 1 point. This scale is used to evaluate the appearance of the colon lining during an endoscopy.
Participants must have current vaccinations according to the immunization program, including vaccinations with live vaccines.
Participants and their legal representatives must provide informed written consent to participate in the study. Participants aged 13 and older must also sign the consent.

Who cannot join the trial?

9 criteria

Patients with any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to similar medications.
Patients who are unable to follow the study procedures or attend scheduled visits.
Patients with a history of drug or alcohol abuse.
Patients who have been diagnosed with a mental health condition that could affect their ability to participate.
Patients who have received certain treatments or medications that could interfere with the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
Verified
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie
Rzeszow, Poland
Verified
Uniwersytecki Szpital Dzieciecy W Lublinie
Lublin, Poland

Trial locations

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Investigated drugs

Vedolizumab
is a medication used in this trial to assess its safety and effectiveness as an induction therapy for pediatric patients with ulcerative colitis. It works by targeting specific proteins in the body to reduce inflammation in the gut, which can help manage symptoms of ulcerative colitis.
Infliximab
is the standard therapy being compared in this trial. It is a medication that helps reduce inflammation by blocking a protein in the body that causes inflammation. It is commonly used to treat various inflammatory conditions, including ulcerative colitis, and is being used as a benchmark to evaluate the effectiveness of vedolizumab in this study.

What is already known about the treatment

Vedolizumab
Vedolizumab is administered through intravenous infusion, typically in a clinical setting. It is currently being studied for its safety and effectiveness in treating pediatric patients with ulcerative colitis. The medication works by blocking a specific protein that causes inflammation in the gut, helping to reduce symptoms of ulcerative colitis. Vedolizumab is classified as a monoclonal antibody, which targets the immune system to decrease inflammation.
Infliximab
Infliximab is also given via intravenous infusion and is used in the treatment of various inflammatory conditions, including ulcerative colitis. It is a well-established medication in medical literature and is being compared to vedolizumab in clinical trials for pediatric patients. Infliximab works by inhibiting a protein called tumor necrosis factor-alpha (TNF-alpha), which plays a role in inflammation. It is classified as a TNF inhibitor, helping to control inflammation and alleviate symptoms.

Investigated diseases

Ulcerative colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of exacerbation and remission. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in genetically susceptible individuals.